Evaluating outcomes of endoscopic submucosal dissection for gastrointestinal lesions
Prospective Evaluation of the Clinical Utility of Endoscopic Submucosal Dissection (ESD) in Western Population
AdventHealth · NCT05468008
This study is trying to see how well a new technique called endoscopic submucosal dissection works for removing gastrointestinal lesions in patients, especially in the esophagus and colon, compared to older methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AdventHealth (other) |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT05468008 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to assess the procedural and clinical outcomes of patients undergoing endoscopic submucosal dissection (ESD) for gastrointestinal lesions, particularly in the esophagus and colon. Patients will receive standard medical care without any experimental interventions. ESD is a newer technique that allows for the complete removal of lesions, potentially leading to better outcomes compared to traditional methods like endoscopic mucosal resection (EMR). The study will analyze the effectiveness of ESD in a population that may differ from those in previous studies conducted primarily in Japan.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older who are scheduled to undergo endoscopic submucosal dissection.
Not a fit: Patients with contraindications to endoscopy or those participating in other conflicting research protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes for patients with esophageal and gastrointestinal lesions.
How similar studies have performed: While ESD has shown success in Japan, this study represents a novel application of the technique in the US population with different lesion characteristics.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Scheduled to undergo ESD Exclusion Criteria: * Any contraindication to performing endoscopy * Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
Where this trial is running
Orlando, Florida
- AdventHealth Orlando — Orlando, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Dennis Yang, MD — AdventHealth Orlando
- Study coordinator: Dennis Yang, MD
- Email: Dennis.Yang.MD@adventhealth.com
- Phone: 407-303-2570
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Esophageal Lesion, Barrett Esophagus, Gastrointestinal Lesions